Needleless secondary access port for IV infusion system

ABSTRACT

A quick-connect, needleless coupling assembly configured to shield its critical areas from contamination by environmental surfaces has a pair of interlocking, flow-through male and female components which may be used as part of a larger medicinal liquid therapy system. The male component has a generally rigid, blunt, open-ended cannula which is recessed with respect to a surrounding concentrically spaced collar so that the open end of the cannula is protected against contact from environmental surfaces which might otherwise contaminate the cannula. The female component has a socket which receives the male cannula to place the two components into liquid flow communication with one another. In the preferred form of the invention, the two components are threadably interlocked with one another, the female component being provided with an internal depressible valve stem which is operated by the rigid cannula when the components are threaded together, thereby opening an anti-back flow check valve within the female component.

This is a division of application Ser. No. 08/475,373, filed Jun. 7,1995 now U.S. Pat. No. 5,624,414 which is a continuation of priorapplication Ser. No. 08/067,394, filed May 25, 1993 (now U.S. Pat. No.5,464,399), which is a continuation of prior application Ser. No.837,263, filed Feb. 18, 1992 (now abandoned).

TECHNICAL FIELD

The present invention relates generally to systems for administeringfluids such as medicinal liquids to patients in hospitals, doctorsoffices, home settings, clinics and emergency field trauma situations,and, more particularly, relates to improvements in flow-through, quickdisconnect and connect couplings used in association with tubings,syringes, vials, bags, and other such equipment commonly associated withmedicinal liquid therapies.

BACKGROUND

In the administration of medicinal liquids using intravenous techniques,it is important and critical to avoid contamination of otherwise steriledevices and to avoid the spread of infections of various kinds throughaccidental needle sticks. Not only are the patients at risk throughoutthe administration of intravenous therapy, but also the care giver andother individuals within the health care environment are exposed toconsiderable risks if appropriate protective measures are not taken atall potential trouble spots within the procedure. Even activities as farremoved from the immediate patient site as the disposal of discarded,used equipment can present significant danger, such as through theinadvertent puncture of the worker by blood-contaminated needlesprojecting through trash bags and the like.

As a consequence of these types of risks, there has been a trend in thehealth care industry toward the reduction and elimination of steelneedles in connection with intravenous therapy. For example, instead ofusing a steel needle to penetrate a port of a catheter which has beeninstalled at an appropriate access point on a patient's body, somecurrently available products utilize a variety of plastic couplings andvalves for the purpose of communicating the catheter with the syringe,tubing, or other medical appliance administered by the practitioner.While such devices are helpful in the sense they reduce the risksassociated with needle sticks, unfortunately, in many instances, thereis still a significant potential for contamination due to exposedcritical surfaces.

Accordingly, one important object of the present invention is to providea quick connect coupling system or assembly which is particularly,although not exclusively, usable in connection with needleless medicinalliquid delivery systems and which lowers the risks of contaminationassociated with current IV therapies, including those which contemplatethe use of steel needles or unprotected plastic cannulas for accessingthe system. In this respect, it is an important object of the inventionto provide male and female components of the assembly which are quicklyand easily connectable and disconnectable from one another while theprojecting, blunt cannula of the male component which establishes liquidflow communication with the female component is shielded from exposureto environmental elements before, during, and after interconnection withthe female component, thereby helping to avoid any contact withcontaminated surfaces and objects.

Another important object of the present invention is to provide a quickconnect and disconnect coupling system which is readily adaptable foruse on a wide variety of system components, such as, for example,syringes, check valves, flexible tubings and flow lines, vials of boththe single dosage and multi-dosage type, injection ports, access sitesassociated with a variety of components, and liquid supply bags andother containers for medicinal fluids. When the invention is used inconnection with syringes, for example, it is contemplated that the malecomponent with its recessed blunt cannula will be disposed on and forman integral part of the syringe body, while the female component withits receiving socket for the recessed cannula is disposed on theinjection port, back flow check valve, or other major part of thesystem. Instead of using a puncturable membrane on drug vials andinjection ports of flexible tubings, the present invention contemplatesthat such equipment will be provided with the female component and backflow check valve of the present invention so that the syringe or otherappliance having the male component of the assembly integrated therewithis readily usable with the modified vial or injection port.

In carrying out the principles of the present invention, it iscontemplated that the recessed, blunt cannula of the male component isprotectively surrounded by an annular collar having an axially endmostextremity that projects outwardly beyond the open end of the cannula. Inthis manner, once a protective sheath or wrapper has been removed fromthe syringe or other appliance to be utilized by the practitioner, theprotective collar becomes that portion of the appliance which is exposedto environmental surfaces and human contact. Consequently, the criticalopen end of the cannula itself remains in a sheltered and guardedposition throughout the manipulation which is always necessary to accessthe system for administering the medicinal therapy.

In its preferred form, the cannula of the male component is sufficientlyrigid as to serve as a means for depressing the valve stem of a normallyclosed valve which may be incorporated into the female component of theassembly whereby to open the valve. The valve stem may be a solid stemwhich, when depressed, allows fluid flow around its external surfacesdue to a change in position of such surfaces relative to the internalportions of the valve chamber. On the other hand, the stem may betubular such that liquid flow is directly through the cannula and intothe tubular open end of the valve stem when the components of thecoupling assembly have been connected together. Preferably, suchcoupling is accomplished by intermeshing threads on the two components.Furthermore, it is preferred that the male cannula have a luer taper inwhich the diameter of the cannula becomes progressively reduced as theopen blunt end thereof is approached, thereby adapting the cannula to bepress-fit into matingly luer-tapered female sockets associated withother components than those having a depressible valve stem.

The male component of the present invention may be attached directly tocurrent design female-ended catheters, ports, and cannulas not providedwith integral back-flow check valve systems.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective illustration of a system suitable for theintermittent administration of a medicinal liquid to a human orveterinary patient utilizing a syringe, straight injection port andcatheter provided with a quick-attach, needleless coupling in accordancewith the principles of the present invention;

FIG. 2 is a perspective illustration of couplings of the presentinvention in use not only with a hypodermic syringe, but also with aflexible liquid tubing having multiple Y-type injection sites or portsand a flexible, variable volume liquid supply bag which is adapted to beconnected with such flexible line;

FIG. 3 is an enlarged, fragmentary, perspective view of one of theY-type injection sites with an internal anti-backflow check valve in thesupply tubing of FIG. 2;

FIG. 4 is an enlarged, fragmentary, perspective view of the end of asyringe provided with the male component of the present invention;

FIG. 5 is a fragmentary, longitudinal, cross-sectional view of the malecomponent of the assembly on the syringe of FIG. 4;

FIG. 6 is a fragmentary, elevational view of the female component of thepresent invention formed upon an appliance such as the receiving end ofthe injection port of FIG. 3, the protective circumscribing wall of thefemale component being partially broken away to reveal internal detailsincluding a tubular, depressible valve stem of an anti-backflow checkvalve associated with the female component;

FIG. 6a is a fragmentary, elevational view of the female component ofthe present invention formed upon the receiving end of a second type ofinjection port in which the associated anti-backflow check valve has asolid, depressible valve stem;

FIG. 7 is an enlarged, fragmentary view of the coupling assembly withportions broken away to reveal details of construction and illustratingthe male and female components of the coupling firmly connected togetherin liquid flow communication with one another, the female componentbeing integrated with a back flow check valve having a depressible,tubular stem which has been depressed from its phantom line position inFIG. 8 to its solid line, open position;

FIG. 8 is a fragmentary, elevational view on a reduced scale of thequick connect coupling of the present invention used in connection witha drug vial, rigid liquid supply container or the like in which the twomajor components of the assembly are intercoupled as illustrated in FIG.7;

FIG. 9 is a fragmentary, perspective illustration of a prior art syringehaving an exposed, unprotected and outwardly projecting male cannula;

FIG. 10 is a fragmentary, longitudinal, cross-sectional view of theprior art syringe of FIG. 9;

FIG. 11 is a fragmentary, elevational view of a prior art femalecoupling component, the exterior sidewall of the component being brokenaway to reveal internal details;

FIG. 12 is a fragmentary, perspective view of the prior art femalecomponent of FIG. 11;

FIG. 13 is a fragmentary, elevational view with parts shown incross-section of the prior art male and female components connectedtogether and showing the female component integrated as part of a backflow check valve having a depressible, tubular valve stem; and

FIG. 14 is a largely elevational view of a straight injection porthaving male and female components in accordance with the presentinvention formed at its opposite ends and including an internal,anti-backflow check valve.

DETAILED DESCRIPTION

The quick-attach coupling assembly of the present invention may beutilized in connection with a number of appliances or devices used bythe health care practitioner. In FIG. 1, for example, the couplingassembly 10 is shown in use with a hypodermic syringe 12 and a straightinjection port 14 that connects to an intravenous catheter 15 of thetype which is anchored on the skin of the patient by tape 16 or othersuitable means so that the intravenous catheter remains stabilizedwithin the vein of the patient even during changes of the syringe 12.

As particularly shown in FIGS. 4, 5, 6 and 6a, the coupling assembly 10of the present invention broadly comprises a pair of interconnectablecomponents 18 and 20 which may be incorporated into and made integralparts of various components of a medicinal liquid supply system. InFIGS. 4 and 5, it will be appreciated that the male component 18 of theassembly 10 is incorporated into the discharge end of the syringe 12,the main cylindrical body of the syringe 12 being denoted by the numeral22 in FIGS. 4 and 5. The cylindrical body 22 has an inclined, annularend wall 24 that tapers toward the male component 18. A transverse,internal end wall 26 of the body 22 has an orifice 28 disposed on theaxial centerline of the body 22.

The male coupling component 18 is fixedly secured to the transverse endwall 28 such as by integral molding therewith and includes anessentially rigid cannula 30 having a central bore 32 registered withthe orifice 28 and an open, blunt end 34. The open blunt end 34 of thecannula 32 has the effect of establishing a liquid flow passage throughthe component 18 and the body 22 of the syringe 12 defined by the bore32 and the interior chamber 36 within the hollow body 22. In itspreferred form, the cannula 30 is disposed in concentric relationshipwith the body 22 on the longitudinal axis of the latter. Furthermore, inits preferred form, the cannula 30 is provided with a luer taper,progressively reducing in diameter as the blunt end 34 is approachedfrom the transverse end wall 26.

The male component 18 also includes an elongated, annular collar 38which circumscribes the cannula 30 in radially spaced relation therewithand is fixedly joined to the cylindrical body 22 at the intersection ofthe inclined end wall 24 with the transverse end wall 26. The collar 38is concentric with the cannula 30 and is substantially longer than thelatter so as to present an axially endmost extremity 40 that is locatedoutwardly beyond the blunt end 34 of the cannula 30. Thus, the end 34 ofcannula 30 is substantially recessed with respect to the end extremity40 and is protectively shielded by the latter.

An annular space 42 is defined within the collar 38 by virtue of thelarge internal diameter of the collar 38 compared to the outsidediameter of the cannula 30, such space 42 being used to receive aportion of the female component 20 as will hereinafter be made clear. Aseries of internal threads 44 are formed on the interior surface of thecollar 38, extending from the endmost extremity 40 to the transverse endwall 26 for use in releasably connecting the female component 20 withthe male component 18.

The female component 20 has an elongated, annular outer wall 46 that isof slightly smaller outside diameter than the inside diameter of thecollar 38. Threads 48 at the axially outermost end of the wall 46 areconfigured to mate with the internal threads 44 of the male component 18such that the threads 44 and 48 serve as structure for removablyconnecting the components 18 and 20 together when the components areassembled as illustrated in FIG. 7. The annular wall 46 defines an openended, elongated receiving socket 50 having a diameter large enough toaccept the cannula 30 of the male component 18 when the components 18and 20 are connected together. The socket 50 may be communicateddirectly with an internal path (not shown) for liquid flow through thecomponent 20 or, or in its preferred form, the component 20 may beincorporated into an anti-back flow check valve of well-known design.One such check valve is disclosed in U.S. Pat. No. 4,535,820 in the nameof Raines. Such check valve is commercially available from BurronMedical, Inc., of Bethlehem, Pa, and is marketed as a component of thecompany's "Safsite Extension Sets", commonly being referred to as a"reflux valve". Such valve is also disclosed in a publicly availablesales brochure titled "Remove the Risk . . . By Removing the Needle"published by Burron Medical, Inc. Such sales brochure and said U.S. Pat.No. 4,535,820 are hereby incorporated by reference into the presentdisclosure as need be for a full and complete understanding of thepresent invention.

In the event that the female component 20 is incorporated into a checkvalve of the above-described type, the socket 50, instead of beingdirectly communicated with a liquid flow path through the component 20,receives a tubular, depressible valve stem 52 associated with a checkvalve housed within a main body 54 of the device. The valve stem 52 hasa blunt open end 56 that has an internal path 58 leading away from theopen end 56 to other portions of the valve. In the normally closedposition of FIG. 6, the valve stem 56 maintains the valve (not shown)closed to preclude fluid flow through the main body 54 and the remainderof the system to which it is coupled, while when the stem 52 isdepressed, the internal valve is forced open to allow fluid flow.

FIG. 6a illustrates a second preferred form of check valve with whichthe female component 20 may be associated. In this particular form, thedepressible valve stem 52a is solid rather than tubular. When depressed,the stem 52a opens a fluid flow pathway around external rather thaninternal surfaces thereof. One such suitable solid stemmed valve isavailable from Halkey-Roberts, Inc., of St. Petersburg, Fl. Such valveis also disclosed in U.S. Pat. No. 3,831,629 to Mackal, et al., which ishereby incorporated by reference into this specification as need be fora full and complete understanding of the present invention.

FIG. 7 illustrates the manner in which the components 18 and 20 may beremovably connected together when the male component 18 is part of asyringe such as the syringe 12 and the female component 20 is part of areflux valve of the type above described in FIG. 6. It will beappreciated that when the components 18 and 20 are brought into axialalignment with the annular wall 46 of the female component 20 inregistration with the annular space 42 of the male component 18,relative rotation of the two components while they are moved axiallytoward one another causes the threads 44 and 48 to matingly interengageand draw the female component 20 up into the male component 18. Asrelative rotation in the appropriate direction continues, the open end34 of the rigid cannula 30 comes to bear against the similarly open end56 of the valve stem 52 at the dotted line location indicated by thereference numeral 60. Continued relative rotation of the two partscauses the valve stem 52 to be depressed by the cannula 30, opening theinternal valve within the body 54 and establishing liquid flowcommunication between the body 54 and the interior chamber 36 of thesyringe 12. If a valve having the solid valve stem 52a of FIG. 6a isused rather than the tubular stem 52, the action will be similar to thatdescribed with respect to FIG. 7 but liquid leaving the cannula 30 willescape through a cross slot or the like in the depressed solid stem 52aand enter the socket 50 for movement through the valve externally of thestem 52a.

In order to disconnect the syringe 12 from the body 54, it is onlynecessary to relatively rotate the syringe 12 and the body 54 in theopposite direction from that utilized to secure the parts together,which causes the valve stem 52 to yieldably return to the dotted lineposition 60 and reestablish closure of the internal valve. A suitableclosure cap (not shown) may be applied to the otherwise open end of thefemale component 20 after disconnection from the syringe 12. If desired,a likewise suitable closure may be provided for the male component 18 ofthe syringe 12.

FIG. 8 shows how the valve body 54 incorporating the female component 20may be utilized in connection with a rigid liquid supply container or adrug vial 62, in lieu of a rubberized or plastisized membrane port suchas currently commercially available. In either the single or multi-dosetype, the vial 62 and its female component 20 must have a suitableanti-backflow valve or other type shut-off flow valve associated with itto prevent liquid flow and maintain content sterility during periods ofnon-use.

FIGS. 2 and 3 show the male and female coupling components 18, 20utilized in connection with a flexible dispensing bag and supply tubingsystem. In this contemplated manner of use, the flexible supply bag 62contains a medicinal liquid which will be delivered to an injection siteor other location such as represented by the intravenous catheter 15 inFIG. 1. The bag 62 has been adapted with a single filling and dischargeport 64 equipped with the female component 20 of the quick couplingsystem provided with an integral anti-backflow valve 65 which isnormally closed but opens upon interconnection of the components 18 and20. The male coupling component 18 is fitted onto the uppermost end ofthe flexible tubular supply line 66.

The line 66 in turn leads to a Y-type access port broadly denoted by thenumeral 70 (see, also, FIG. 3) which maintains communication between theline 66 and a second length of tubing or line 72, but which may beaccessed by a syringe 74 or other similarly male ended supply line viathe female end 20 of the access port 70 for the injection of additionalmedicinal liquids if desired. Having the female component 20 of thepresent invention on the access port 70 facilitates quick connect anddisconnect of the syringe 74 or IV supply tubing which likewiseincorporates the male component 18 of the present invention.

The line segment 72 at its end remote from the Y-type access port 70 maybe provided with one or more additional Y-type access ports 78 which areof similar design to the access port 70 and which in their preferredform are provided with the female component 20 of the instant invention.

It will be appreciated that depending upon the particular type ofintravenous system which is set up, it may be desirable to use a part orcombination of parts which ultimately has two of the male components 18at opposite ends thereof. For example, this would permit the free end ofthe Y-type access port 78 in FIG. 2 to be connected to a fitting orintermediate coupling having the male component 18 thereon, which wouldin turn be connected directly to the female component 20 associated withthe intravenous catheter in FIG. 1. Likewise, in some situations it maybe desirable to have a single component or a combination of componentsarranged in such a manner that opposite ends of the resulting assemblyare both provided with a female connecting component 20.

FIG. 14 shows a straight injection port 80 in which the male component18 of the present invention is formed at one end and the femalecomponent 20 of the present invention is formed at the opposite end. Thefemale component 20 chosen for illustration has the tubular, depressiblevalve stem 52 therein, although it will be appreciated that the solidvalve stem 52a could alternatively be provided. The injection port 80has an internal anti-backflow check valve of suitable design aspreviously discussed.

FIGS. 9 through 13 are illustrations of prior art quick-attach couplingcomponents. As illustrated in FIG. 9 and FIG. 10 in particular, theprior male coupling component 100 included a rigid, tubular cannula 102which projected outwardly beyond the endmost extremity 104 of a annularcollar 106 circumscribing the cannula 102 in spaced, concentricrelationship therewith. Consequently, the cannula 102, once unsheathedfrom a protective wrapper or the like, was exposed to contamination bycontact with environmental surfaces, including but not limited to thepractitioner's own hands and fingers.

The female component 108 of the prior art as shown particularly in FIGS.11 and 12, included an annular outer wall 110 defining an internal,cylindrical socket 112 for reception of the cannula 102 associated withthe male component 100. The prior art female component 108 could also beintegrated with a valve body 114 containing a suitable anti-back flowcheck valve actuated by a tubular, open ended, depressible valve stem116 situated axially within the socket 112 in disposition fordepressible actuation by the cannula 102 when the components 100 and 108were coupled together in the manner illustrated in FIG. 13. Intermeshingthreads 118 and 120 on the interior wall of the collar 106 and theexposed outermost end of the wall 110 of the female component 108 servedas structure for holding the components 100 and 108 releasably connectedtogether.

It is contemplated that the quick-connect coupling components of thepresent invention may be manufactured from a suitable plastic such as apolystyrene material. In this manner, the components are readilymanufacturable at a relatively reasonable cost and can be treated asdisposable components. They may also form a part of a completelyneedleless intravenous infusion system so that the risk of needle stickinjuries, especially when the practitioners are in a hurry, can bealmost completely eliminated.

It will be appreciated that current therapy techniques utilizing needlespresent a number of significant risks directly associated with theneedles. If a sharpened needle is to be used to puncture a rubberizedinjection port, such port must first be cleansed with alcohol/betadineto ensure sterility prior to the puncture.

After unsheathing the needle, the needle must be maintained as a steriledevice throughout puncturing of the port, the injection of themedication, and the subsequent removal of the needle from the port.Then, the needle must be safely discarded without contaminating anythingin the environment.

Of course during discard of the needle-bearing syringes or the needlesthemselves, there is a likelihood that they will accidently puncture thecare giver or ancillary staff responsible for carrying out theirdisposal. This is made all the more serious by the fact that once theneedles have been used with the patient, they are contaminated with thebody fluids of the patient and are therefore hazardous carriers ofpotentially lethal pathogens for all persons who may be accidentallypunctured by them. Applying a protective cap or sheath to the needleafter use and prior to disposal is desirable yet risky because the extraoperation presents an extra opportunity for needle stick.

Furthermore, it is quite possible with needles and current plastic fluidaccess spikes to accidentally puncture the fluid volume devices such asbags or containers typically utilized to hold a medicinal liquid to beadministered to a patient. When an erroneous puncture occurs, the entirefluid volume is contaminated. Moreover, a leak point is produced whichpotentially exposes the care giver and others to potentially toxicsubstances.

Even in prior systems having non-metal spikes and the like forpuncturing sealing membranes or other structures, such puncturingdevices are still exposed to contamination by environmental surfaces.Absolutely meticulous adherence to aseptic techniques throughout thepuncturing and medicinal administration process must be ensured.

Accordingly, it should be apparent that the present invention provides asignificant advancement in this art by eliminating serious risksinherent in present systems while maintaining user friendly componentsat a reasonable cost.

Although preferred forms of the invention have been described above, itis to be recognized that such disclosure is by way of illustration only,and should not be utilized in a limiting sense in interpreting the scopeof the present invention. Obvious modifications to the exemplaryembodiments, as hereinabove set forth, could be readily made by thoseskilled in the art without departing from the spirit of the presentinvention.

The inventor hereby states his intent to rely on the Doctrine ofEquivalents to determine and assess the reasonably fair scope of hisinvention as pertains to any apparatus not materially departing from butoutside the liberal scope of the invention as set out in the followingclaims.

I claim:
 1. An improved, needleless secondary access port for use in aneedleless IV infusion system as a site that provides secondary accessto a patient's vascular system, said port comprising:a generallyY-shaped, hollow body having a pair of generally mutually converginginlets and a single outlet communicating internally of the body withboth of said inlets, one of said inlets being adapted for permanentconnection with one segment of a supply line from a source of supply ofliquid, and said outlet being adapted for permanent connection withanother segment of the supply line leading to a patient; a normallyclosed check valve associated with the other of said inlets formaintaining said other inlet closed unless intentionally opened by adevice that has become detachably secured to the body; and releasablelocking structure on the body at said other inlet for detachablysecuring a device to the body in a manner to open said check valve, saidlocking structure on the body comprising a female luer lock endpermanently secured to the body and including a generally cylindrical,annular wall having external threads disposed for meshing engagementwith internal threads on the device to be attached to the female luerend, said check valve including a one-piece, resilient poppet yieldablybiased into a closed position an having actuating stem that projectsaxially into surrounded relationship with the wall of the female luerend for opening depression by the device attached to the secondaryinlet.